Status:
COMPLETED
A 12-Week Study To Assess The Safety Of Fluticasone Propionate/Salmeterol 100/50 Hydrofluoroalkane (HFA) Versus Fluticasone Propionate 100 HFA In Children With Asthma
Lead Sponsor:
GlaxoSmithKline
Conditions:
Asthma
Eligibility:
All Genders
4-11 years
Phase:
PHASE3
Brief Summary
This study is to assess the safety of an investigational drug in children 4 to 11 years of age who have asthma. The subjects will attend 7 clinic visits, of which up to 3 will be in the morning, and h...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Must have asthma.
- Must be currently taking an inhaled corticosteroid.
- Must be able to attend 7 clinic visits, of which up to 3 will be in the morning, and have lung function tests that are at least 60% of normal (AM FEV1 or PEF).
- Have a historical or current FEV1 or PEF reversibility of \>=12%.
- Exclusion criteria:
- Has ever had life-threatening asthma (for example respiratory arrest, mechanical ventilation).
- Has a current ear or respiratory tract infection.
- Has ever had any other major illnesses (such as cystic fibrosis, heart problems, tuberculosis).
Exclusion
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
351 Patients enrolled
Trial Details
Trial ID
NCT00441441
Start Date
February 1 2007
End Date
January 1 2008
Last Update
December 16 2016
Active Locations (55)
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1
GSK Investigational Site
Huntington Beach, California, United States, 92647
2
GSK Investigational Site
Long Beach, California, United States, 90806
3
GSK Investigational Site
Long Beach, California, United States, 90808
4
GSK Investigational Site
Riverside, California, United States, 92506